The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply
Job Summary
The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply.
You will manage India regulatory activities for medical devices, including registrations, renewals, variations, labelling compliance and lifecycle management in compliance with India Medical Device Rules (MDR) 2017 and other applicable regulations and requirements.
At Cytiva we believe in designing a better, more sustainable workforce and recognize the benefits of flexible, remote working arrangements for eligible roles.
Matching Summary
The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply.
Skills & Requirements
Must-have
India medical device regulatory activities
India CDSCO submissions
ASEAN regulatory frameworks
ISO 13485 requirements
Veeva RIM
Nice-to-have
Continuous improvement culture
Proactive risk mitigation
Global regulatory frameworks
Flexible remote working
Key Requirements
Minimum 3 years RA experience in medical device industry
Bachelor’s Degree/ Diploma in Life Sciences, Engineering or related
Experience with India CDSCO submissions
Good knowledge of India MDR & ASEAN regulatory frameworks
Ability for minimal travel required at 10% or less